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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Difficult to Advance (2920); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
Patient Problems Erythema (1840); Paralysis (1997); Swelling (2091); Weakness (2145); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2019
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: 05-jul-2020, udi#: (b)(4), implanted: (b)(6) 2019, product id: 8596sc, serial/lot #: (b)(4), ubd: 26-apr-2019, udi#: (b)(4), implanted: (b)(6) 2019. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient who was receiving 1000 mcg/ml of fentanyl at 200 mcg/day and 10 mg/ml of bupivacaine at 2 mg/day via an implantable pump for spinal pain. On (b)(6) 2019, it was reported that during a catheter replacement on (b)(6) 2019, the hcp had difficulty advancing the new catheter and could not aspirate from the catheter. The rep reported that this was a "weird" case and they had trouble "threading" the catheter into the intrathecal space. The hcp determined it was not in the epidural space and pushed contrast through confirming that dye was able to propel through the catheter. However, the hcp could not "retract" the contrast. It was reported that they were never able to aspirate successfully during the case and never got csf back. The hcp believed that it was because there was too much hardware in the spine. The patient reported to the rep that after the replacement they could not move their right foot but could still feel it. No further complications were reported.
 
Manufacturer Narrative
Product id: 8598a, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: catheter; product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative on 2019-mar-13. It was reported that the catheter was removed on (b)(6) 2019 and it was unknown how the patient was doing post-removal.
 
Manufacturer Narrative
Updated to reflect the information received on 2019-mar-14. Corrected to reflect the report of the serious injury received on 2019-mar-13. Device code (b)(4) was added to reflect the information received on 2019-mar-14. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via a manufacturer's representative on 2019-mar-14. It was reported that the cause of the patient's inability to move their right foot was unknown. The hcp noted that they were unable to tell where the catheter was in the spine on the ct and mri. However, the difficulty threading the catheter and being unable to aspirate the catheter was considered resolved. No further complications were reported.
 
Manufacturer Narrative
Patient weight updated to reflect the information received on 2019-apr-23. Outcomes attributed to adverse event updated to include hospitalization per information received on 2019-apr-23. Event description updated to include information received on 2019-apr-23. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via a clinical study on 2019-apr-23. It was reported that the hcp received a voicemail from the patient on (b)(6) 2019 who reported that their "right leg has been paralyzed" since surgery. The patient later clarified that they were unable to wiggle their toes or bear weight on the right leg. It was noted that the patient was experiencing leg weakness and a loss of mobility. The patient was sent for a lumbothoracic mri without contrast on (b)(6) 2019. No changes related to procedure or implanted device were noted following the mri on (b)(6) 2019. The physician's assistant caring for the patient called to inform of redness and swelling around the surgery sites following the catheter explant on (b)(6) 2019. The patient was to be sent to the pain clinic for aspiration after they were discharged. On (b)(6) 2019, the hospital informed the hcp that the patient was being treated in the rehab center. The patient was not discharged to the pain clinic. It was reported that this event required in-patient or prolonged hospitalization as well as an emergency room visit. The event was ongoing. The etiology indicated the event was possibly related to the device or therapy and was possibly related to the implant procedure. No further complications were reported.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8413813
MDR Text Key139239393
Report Number3004209178-2019-05080
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/12/2019 Patient Sequence Number: 1
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